Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

Masimo Corporation2 sites in 1 country10 target enrollmentMarch 12, 2018

ConditionsRespiration Rate

Overview

Phase: N/A
Intervention: Not specified
Conditions: Respiration Rate
Sponsor: Masimo Corporation
Enrollment: 10
Locations: 2
Primary Endpoint: Accuracy of Acoustic Respiration Rate (RRa)
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).

Registry

clinicaltrials.gov

Start Date

March 12, 2018

End Date

August 31, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects weighing up to 10kg
•Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
•The parent/legal guardian has given written informed consent/assent to participate in the study.

Exclusion Criteria

•Subjects with underdeveloped skin
•Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
•Subjects deemed not suitable for the study at the discretion of the investigator.

Outcomes

Primary Outcomes

Accuracy of Acoustic Respiration Rate (RRa)

Time Frame: One study visit lasting up to 60 minutes.

Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref.